You are here

Guidance for completing the application form for an assessed listed medicine

Version 1.2, August 2018

20 August 2018

Book pagination

Introduction

From March 2018, complementary medicines sponsors have the option to enter their medicine in the Australian Register of Therapeutic Goods (ARTG) via a new pathway for listing - the assessed listed medicines pathway.

To be a listed medicine on the Australian Register of Therapeutic Goods (ARTG) through the assessed listed medicines pathway a product:

  • can only contain certain low risk ingredients draw exclusively from the permitted ingredients list
  • must be manufactured in accordance with the principles of Good Manufacturing Practice (GMP)
  • make at least one 'intermediate level indication' as described in the Assessed listed medicines evidence guidelines.

Medicines listed through the assessed listed medicines pathway will be included in the ARTG following self-certification by the applicant of the safety and quality of the product, and TGA assessment of the efficacy evidence supporting the proposed indications.

The information below will assist you in providing the required information for completing (and submitting) an application for an assessed listed medicine (either for new ARTG entries or changes to existing ARTG entries).

Assumed knowledge

It is assumed that users will have an understanding of the regulation of complementary medicines in Australia and the legal obligations of a sponsor of a listed medicine. For more information, refer to the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) and the Assessed listed medicines evidence guidelines.

It is assumed that the applicant has an existing client ID in the TGA Business services (TBS) portal. If not, the applicant will need to apply for a client ID through TGA Business services before lodging the application.

Accessing help

Email

For listed medicine application and submission enquiries, please email complementary.medicines@health.gov.au with as much information as possible, such as a copy of the problem application or screenshots of any error messages received.

For questions about TBS related issues and access you can contact the TBS helpdesk on ebs@health.gov.au.

Phone

You can phone Complementary medicines on 1800 020 653 or 02 6232 8634.

You can phone the TBS helpdesk on 1800 010 624.

Accessing the application form

Currently the electronic application form is accessed through the TGA Business Services portal. You will also need to complete the separate downloadable Module 1.2.1: Assessed listed medicine general application information form with the formulation and manufacturer details, and include it in Module 1.2.1 of your CTD Module 1 application dossier. The electronic upgrades to support the assessed listed medicines will be implemented late 2018.

Book pagination